Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
For the treatment of infections due to susceptible organisms.
The indications include:
Clarithromycin tablets are indicated in adults and children 12 years and older.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Further information:
H. pylori is strongly associated with peptic ulcer disease. Ninety to 100% of patients with duodenal ulcers are infected with this agent. Eradication of H. pylori has been shown to markedly reduce the rate of duodenal ulcer recurrence, thereby reducing the need for maintenance anti-secretory therapy.
In a well-controlled double-blind study, H. pylori infected patients with duodenal ulcer received clarithromycin 500mg t.i.d for 14 days with omeprazole 40mg daily for 28 days.
Clarithromycin has been used in other treatment regimens for the eradication of H. pylori. These regimens include: clarithromycin plus tinidazole and omeprazole; and clarithromycin plus tetracycline, bismuth subsalicylate and ranitidine.
The usual recommended dosage of clarithromycin in adults is one 250mg tablet twice daily. In more severe infections, the dosage can be increased to 500mg twice daily. The usual duration of therapy is 6 to 14 days.
Children under 12 years: The use of clarithromycin tablets has not been studied in children under 12 years. Therefore, children under 12 years of age should use clarithromycin oral suspension only.
Children over 12 years: As for adults.
In patients with renal impairment with creatinine clearance less than 30 ml/min, the dosage of clarithromycin should be reduced by one-half, i.e.: 250mg once daily or 250mg twice daily in more severe infections. Treatments should not be continued beyond 14 days in these patients.
The recommended starting dose is 500mg b.i.d. If no clinical or bacteriological response is observed in 3 to 4 weeks, the dose may be increased to 1000mg b.i.d. Treatment of disseminated Mycobacterium avium complex (MAC) infections in AIDS patients should be continued, as long as clinical microbiological benefit is demonstrated. Clarithromycin should be used in conjunction with other anti-mycobacterial agents.
Treatment of other non-tuberculous mycobacterial infections should continue at the discretion of the physician.
The recommended dosage of clarithromycin in adults is 500mg twice daily.
Triple Therapy (7 days): Clarithromycin (500mg) twice daily and a proton pump inhibitor (at the approved daily dose)* should be given with amoxicillin 1000mg twice daily for 7 days.
Triple Therapy (7 days): Clarithromycin (500mg) twice daily and a proton pump inhibitor (at the approved daily dose)* should be given with metronidazole 400mg twice daily for 7 days.
Triple Therapy (7-10 days): Clarithromycin (500mg) twice daily should be given with omeprazole 20mg daily and amoxicillin 1000mg twice daily for 7-10 days.
* see individual data sheets/SPCs for the dose recommendations for H. pylori eradication.
For oral administration.
Food does not affect the bioavailability.
Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested eight grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia, and hypoxaemia.
Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
3 years.
Store below 25ºC.
Tablets are packed into PVC/PVDC-Al blisters. Boxes of 14, 16 and 20 tablets.
Not all pack sizes may be marketed.
None.
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